FDA: Yes, you Did! Sunland: No, we Didn’t!

The FDA found that between June of 2009 and August of 2012, Sunland Inc. had distributed, or cleared for distribution, portions of 11 lots, or daily production runs, of peanut or almond butter after its own testing program identified the presence of at least one of nine different Salmonella types (Arapahoe, Bredeney, Cerro, Dallgow, Kubacha, Mbandaka, Meleagridis, Newport, and Teddington) in those lots. Two of these lots showed the presence of the outbreak strain of Salmonella Bredeney.

Last night Sunland President and CEO Jimmie Shearer posted his response:

At no time in its twenty four year history has Sunland, Inc. released for distribution any products that it knew to be potentially contaminated with harmful microorganisms. The Company has followed internal testing protocols that it believed resulted in the isolation and destruction of any product that did not pass the test designed to detect the presence of any contaminants. In every instance where test results indicated the presence of a contaminant, the implicated product was destroyed and not released for distribution. The Company believed at all times that its response was sufficiently robust such that any product which might be contaminated was isolated and destroyed.

Sunland, Inc. continues to cooperate openly with FDA to address matters related to the recent recall of its products and the inspection of its manufacturing facilities. Sunland has submitted a comprehensive point by point response to the Form 483 observations issued at the close of the inspection. The Company’s response is currently under review by the agency. We believe that drawing any inferences much less conclusions about the Company’s practices based solely on the observations as set forth in the Form 483 without considering the Company’s response would be wholly premature and unduly prejudicial to Sunland. The Company believes that its response to the Form 483 will not only help the agency understand the Company’s decision-making process but also lead the agency to confirm that such decision-making was, at all times, conducted in good faith. In deference to the agency’s review process, the Company will not publicly discuss its responses until the agency has completed its review.

Did Sunland ship tainted product? Well, we know they did. Did Sunland ship it knowingly? I think Congressional hearings to get all this on the table would be important.